Odyssey Systems has an exciting new opportunity for a Clinical
Research Coordinator (CRC) in support of the Clinical Investigation
Department and at Naval Medical Readiness and Training Command,
Portsmouth (NMRTCP). CRCs support the Department Head of the CID
and coordinate and conduct human clinical research in conjunction
with the Principal Investigators (PI) of IRB-approved research
protocols at NMCP. The mission of NMRTCP is to support the national
interests of the United States by providing professional education
and development, providing quality patient care, being responsive
and ready for deployment, and taking care of each other as
shipmates. NMRTCP conducts biomedical research in general surgery,
psychology, otolaryngology, pediatrics, nursing research,
orthopedics, women’s health, and emergency medicine, which is
relevant to the Graduate Medical Education Program.
Duties include, but not limited to:
Coordinate the research activities of IRB-approved study
protocols. Protocols will include both pediatric and adult
patients, animals and human anatomical specimens (including
cadavers). The specific protocol(s) requiring CRC support shall be
determined by the Department Head of CID.
Support and conduct research in conjunction with the PIs of the
assigned IRB-approved protocols.
Support to the Department Head of CID and the PIs of each protocol
in accordance with written policies and procedures as set forth in
Title 21 of the Code of Federal Regulations, NMCP, and Bureau of
Medicine & Surgery (BUMED) instructions Recruit and screen subjects
using protocol inclusion/exclusion criteria.
Administer and collect questionnaires from patients and healthcare
providers at study sites.
Observe patient care teams and complete teamwork questionnaires at
local study sites.
Assign appropriate subject identification number per protocol
Ensure that the consent process has taken place effectively and all
questions are answered satisfactorily and documented.
Input research data into database.
Report adverse events to the IRB-protocol PI for submission to
governing agencies and sponsors as required by protocol and
Evaluate compliance of research subject to protocols and complete
documentation of status and progress.
Conduct telephone or face-to-face interviews and mail government
approved information for follow-up visits.
Maintain detailed documentation of the research study including but
not limited to individual patient files, databases as required by
the protocol and the Investigators File Binder/Regulatory
In collaboration with CID, PIs, and assigned medical monitor,
prepare reports and other correspondence regarding the research
protocol for the IRB, granting agencies, industry sponsors, and
other organizations as required by regulation and/or the
In collaboration with key research personnel and investigators,
process and prepare specimens for lab analysis and shipping.
Interact on a regular basis with the PI regarding the conduct of
the research study.
Attend local conferences (approved by the COR) and other meetings
as required by the protocol, the PI, or the sponsoring agency.
Respond to research participants in an efficient and timely manner
and documents interactions appropriately.
Observe safety regulations when working in ambulatory care spaces
and inpatient wards (such as the use of government provided
personal protective equipment (PPE)).
Provide other research support duties that are within the scope of
One of the following minimum requirements must be met (A or
A: BS degree and 2+ years experience as a CRC within the last 5
B: Current certification as a Certified Clinical Trial
Investigator (CCTI), Certified Clinical Research Coordinator
(CCRC), or Certified Clinical Research Professional (CCRP) from the
Association of Clinical Research Professionals (ACRP) or the
Society of Clinical Research Associates (SoCRA).
Other requirements include:
Working knowledge of U.S. Federal government regulations
regarding the conduct of human clinical research.
Complete human protection training developed by the Collaborative
Institutional Training Initiative (CITI) within one month from the
start of performance.
Must be proficient in medical record reviews and searches. Must
have experience in the use of clinical computer systems such as
CliniComp (Essentris), Cerner (MHS-Genesis) or SPSS.
Proficient in scheduling and communicating with participants.
Proficient in writing and editing to assist PIs in preparation of
their manuscripts, scientific abstracts, and/or research
Work requires concentration, periods of standing and walking on a
regular basis; must work well under pressure, in often changing
conditions and research workload.
Ability to exercise independent judgment to determine appropriate
action and priorities in the performance of duties outlined
Must be a US citizen with the ability to obtain a favorable
NACLC T3 security investigation prior to start
Odyssey Systems Consulting Group, is an innovative small
business committed to providing world-class technical, management,
and training support services to government and public sector
clients. We focus on people, processes, and performance to deliver
superior results. Since our inception in 1997, our commitment to
mission success and customer satisfaction has been recognized with
exponential growth and exceptional past performance ratings. We
accept challenging assignments and drive projects from the planning
stages, through implementation, and into operations and
Equal Opportunity Employer/Protected Veterans/Individuals with